FDA Radiology AI Devices

Clarius Median Nerve AI is a machine learning-based software integrated with the Clarius Ultrasound Scanner system. It automatically segments the median nerve and measures its cross-sectional area in ultrasound images of the wrist and forearm. This tool assists trained healthcare professionals by providing semi-automated measurements to support clinical assessment in musculoskeletal ultrasound imaging, improving efficiency and accuracy while allowing manual adjustments.

BrightHeart View Classifier is an AI-powered software that automatically analyzes fetal ultrasound images and video clips to identify standard views of the fetal heart during scans. It helps healthcare professionals by improving the acquisition and interpretation of fetal heart ultrasound exams, making fetal heart imaging more efficient and consistent.

The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is software designed to help physicians analyze and observe images from ultrasound examinations. It supports data from specific diagnostic ultrasound systems and includes AI-enabled features for advanced cardiac motion tracking and measurement, aiding clinical decision-making in hospital and clinical settings.

LARALAB is an AI-powered medical imaging software that helps cardiologists, radiologists, and heart surgeons visualize, assess, and measure cardiovascular structures from medical images. It automates segmentation and measurements to assist in preprocedural planning and postprocedural review, improving workflow efficiency and accuracy in cardiovascular care.

Clarius Prostate AI is an AI-powered ultrasound software tool integrated into the Clarius Ultrasound Scanner system. It assists qualified healthcare professionals by automatically detecting, segmenting, and measuring prostate volume in ultrasound images, helping to streamline clinical workflow and improve prostate assessment accuracy while allowing manual adjustments. It is intended for adult male patients and supports prostate imaging with curvilinear and endo-cavitary scanners.

GBrain MRI is a software tool that automatically segments, quantifies, and reports the volume of signal hyperintensities in brain MR FLAIR images. It helps radiologists by providing quantitative measurements to support the evaluation of brain MRI scans, enhancing clinical assessment without replacing the physician's judgment.

cmAngio® (V1.6) is an AI-based software product designed to assist radiologists by automatically processing radiological images, potentially helping to detect or analyze vascular conditions.

DeepFoqus-Accelerate is an AI-driven software solution designed to improve brain MRI scans by reconstructing accelerated MRI data up to 4 times faster, producing clinical-quality images from undersampled data. It helps radiologists and technologists by enhancing non-contrast brain MRI images from 1.5T or 3T Siemens and GE scanners, making MRI scanning more efficient while maintaining image quality.

Salix Central is a cloud-based software that helps cardiologists and radiologists analyze cardiac CT scans. It assists in identifying coronary plaques, stenosis, and performing calcium scoring, supporting clinical decision-making in assessing heart disease.

Vent Creativity Knee v1.0 (Hermes) is a software tool that processes CT scan images of the knee to segment bones and generate surgical planning data. It uses AI models to accurately identify bone structures and landmarks, aiding clinicians in diagnosis and preoperative planning. The software also supports the creation of physical replicas based on imaging data, facilitating orthopedic applications.